Annals of Health Law
THE CURIOUS CASE OF TRENT ARSENAULT
insemination with the semen from a sexually intimate partner entails
minimal risks.” 143 However, this bluff and condescending statement
ignores the reality that the meaning of those words to officials in
Washington may not reflect the meaning they have to individuals
attempting to start a family through methods that are, if uncommon, still
freighted with intimacy.
Of course, the hazard posed by insemination with a SIP’s semen varies
based on the degree to which the attempt to conceive would expose the
recipient to new disease risk. The FDA’s logic applies where the
partnership in question is a monogamous couple that regularly engage in
sexual intercourse and do not take part in individual activities that could
lead to asymmetrical exposure. Not only does that describe only a subset of
sexually intimate relationships, but it privileges this subset under a federal
regulatory regime.
By leaving SIP undefined, the FDA perhaps recognized that a federal
agency is not institutionally competent to create one definition of SIP
applicable to more than 300 million Americans. Indeed, it is inevitable that
every individual will define this term for him- or herself. Just as individual
persons ultimately arrive at their own sincerely held religious beliefs,
sincerely held beliefs about sex, intimacy, and relationships will differ
based on subjective experience.
Of course, a less generous interpretation of the government’s actions is
supported by CBER’s actions in the Arsenault matter. By leaving SIP
undefined, the FDA can avoid a potential controversy, 144 but raise a
legalistic eyebrow whenever an individual steps out of line and tries
something that transgresses against the unwritten, heterosexually-monogamous definition. For example, in the Arsenault matter, CBER
explicitly claimed that the SIP exemption was created “with the
understanding that such partners would not need to be follow donor
eligibility requirements.” 145 To base a regulation on some unspoken and
undefined understanding about sexually intimate partnerships is, at
minimum, problematic.
Moreover, the FDA’s “understanding” that SIPs are those between
monogamous, sexually active heterosexual couples does not necessarily
flow from the regulations themselves. A broader understanding is
consistent with the preamble language CBER cited in the Arsenault matter.
143. CBER, supra note 132, at 9-10.
144. Lauren Bruce, What Makes a Woman a Woman?, FEMINISTE, (Apr. 4, 2005)
http://www.feministe.us/blog/archives/2005/04/24/what-makes-a-woman-a-woman/
(discussing the controversy of the proposed Unborn Child Pain Awareness Act of 2005,
which defines a woman as solely a female human being capable of becoming pregnant).
